The U.S. FDA granted full approval (Biologics License Application, BLA) to Novavax's COVID-19 vaccine in May 2025, with commercial delivery expected for the 2025-26 season pending strain recommendations.123
Novavax's application for full licensure faced unusual delays; although an April 2025 approval date was set, an FDA deputy commissioner requested additional data, which is atypical for this phase and raised transparency concerns.3
The FDA also requested a new clinical trial and additional postmarketing commitments from Novavax as conditions for approval, following intervention from newly appointed HHS officials.5
Former FDA regulators and observers expressed concern that these delays, additional requirements, and apparent external interventions could signal threats to the FDA's traditionally independent and science-driven approval process, risking political interference.345
The process for Novavax led to uncertainty for other vaccine manufacturers, prompting questions about potential shifting standards and the overall integrity of the COVID-19 vaccine approval system.34
Sources:
1. https://ir.novavax.com/press-releases/2025-05-19-U-S-FDA-Approves-BLA-for-Novavaxs-COVID-19-Vaccine
2. https://www.fda.gov/media/186545/download
3. https://www.cidrap.umn.edu/covid-19/fda-approves-full-license-novavaxs-covid-vaccine
4. https://www.statnews.com/2025/04/27/fda-covid-vaccine-approval-process-novavax-pfizer-moderna/
5. https://www.contagionlive.com/view/fda-requests-additional-trial-novavax-nvx-cov2601-vaccine-prior-approval